Rabies Immunization Concomitant With JEV in Children

This study has been completed.
Sponsor:
Collaborator:
Chiron company: Clinical Research and Medical Affairs
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00703521
First received: June 20, 2008
Last updated: October 23, 2008
Last verified: June 2008
  Purpose

Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries. Including PreP in national childhood immunization programs (EPI) is a viable option.

Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or JEV alone was administered concomitantly one year after primary vaccination. Safety was evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to booster and on days 7 and 28 post-booster, and at two and three years post primary vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA, JEVNA).


Condition Intervention Phase
Rabies
Biological: Rabies vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Three-Year Clinical Study on Immunogenicity, Safety and Booster Response of Purified Chick Embryo Cell Rabies Vaccine (Pcecv) Administered Intramuscularly or Intradermally to 12- to 18-Month-Old Thai Children Concomitantly With Japanese Encephalitis Vaccine

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Estimated Enrollment: 200
Study Start Date: August 2002
Study Completion Date: September 2005
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1,2,3,4,5
  1. Rabies vaccine 1.0 mL IM on day 0, 7, 28,and 1 year
  2. Rabies vaccine 0.5 mL IM on day 0, 7, 28,and 1 year
  3. Rabies vaccine 0.1 mL Intradermal on day 0, 7, 28,and 1 year
  4. Rabies vaccine 0.1 mL Intradermal on day 0, 28,and 1 year
  5. Japanese encephalitis vaccine 0.25 mL subcutaneous
Biological: Rabies vaccine
1.0 mL IM day 0,7,28 and 1 year

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female 12-18 months old toddlers will be included in the study if they;
  • are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
  • are available for all the visits scheduled in the study;
  • have been granted a written informed consent signed by their parents

Exclusion Criteria:

  • a history of rabies immunization;
  • a history of Japanese encephalitis immunization or disease;
  • a significant acute or chronic infectious disease at the time of enrollment;
  • fever > 38.0 degree C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;
  • being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment;
  • administration of any vaccine within the past 14 days before enrollment;
  • known immunodeficiency or an autoimmune disease;
  • known hypersensitivity to neomycin, tetracycline, amphotericin-B;
  • planned surgery during the study period;
  • being enrolled in any other investigational trial contemporaneously;
  • the family plans to leave the area of the study site before the end of study period;
  • history of febrile convulsions;
  • history of wheezing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof. Arunee Sabchareon, Department of Tropical Pediatrics
ClinicalTrials.gov Identifier: NCT00703521     History of Changes
Other Study ID Numbers: M49P2
Study First Received: June 20, 2008
Last Updated: October 23, 2008
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Mahidol University:
rabies vaccination
pre-exposure prophylaxis
rabies virus neutralizing antibody
Antibody response
immunologic memory of rabies vaccination
Safety of rabies vaccination administered in pre-exposure regimens both intramuscular and intradermal routes

Additional relevant MeSH terms:
Encephalitis, Japanese
Rabies
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Rhabdoviridae Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on August 26, 2014